Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients with Cancer

Phase 3

Recruiting

• Conditions: Hematopoietic and Lymphoid System Neoplasm; Stomatitis; Malignant Solid Neoplasm

• Registration Number: NCT05878405
• Lead Sponsor: Mayo Clinic

Brief Summary

This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Study Start: 2023-06-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Active cancer diagnosis
• Admitted to the inpatient setting
• Pain related to oral mucositis
• Experiencing oropharyngeal pain
• Able to provide informed consent

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Exclusion Criteria

• Pediatric age (under 18 years old)
• Pregnant or nursing women
• Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in oral pain	Baseline, 3 days	Pain will be assessed using the standard institutional numeric rating scale where pain level is quantified on a scale of 0 (no pain) to 10 (worst possible pain) pre- and post-intervention (3 times daily for 3 days). Last collected scores will be compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Change in the amount of oral intake	Baseline, 3 days	Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Change in the amount of daily requirements of oral morphine equivalents	Baseline, 3 days	Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output